Protocol HNS 94-001 
REVISED 11/17/94 
Page 2 of 5 
three times a week for two consecutive weeks. After two weeks of rest from 
treatment, courses of three injections weekly for two consecutive weeks are repeated 
on a monthly basis. Injections of adenovirus are continued if tumor continues to 
shrink. If there is absence of tumor shrinkage, evidence of tumor growth, or adverse 
reactions to the adenovirus injections, treatment will be terminated. 
The injections into the tumor are delivered with a skinny needle. If the tumor is 
greater than approximately two inches in size, approximately two teaspoons of virus 
will be injected into the tumor. Smaller tumors, less than two inches, will be 
injected with less than one teaspoon of virus. Multiple injections of virus into the 
tumors will be required with these injections being spaced apart by approximately 
one-half inch each. Numbing medication may be placed on the overlying skin to 
decrease discomfort from injections. 
Patients with tumors of the throat or the voice box may also receive the treatment. It 
may be necessary to remove a part of the tumor surgically or with a laser before the 
treatment with p53 is given. Other patients may require that a tracheostomy is first 
performed. A tracheostomy is a surgical operation to make an opening into the 
windpipe. Certain routine diagnostic studies will be performed before entry into this 
trial. These involve local examination of the tumor by inserting an instrument with a 
light into the throat. 
If previous specimens are insufficient for laboratory studies related to this research, 
additional biopsies will be needed. The treatment will be repeated monthly as long 
as there is evidence that the tumor is not growing. 
The experimental treatment and costs related to the patient’s participation in this 
research and which include clinical examinations, biopsies, and other forms of testing 
will be provided free to the patient. A maximum of 42 patients will be entered in 
this study. Twenty one patients may have injections of adenovirus with surgery and 
twenty one patients may have injections of adenovirus without surgery. 
The patient’s course will be followed indefinitely. Dr. dayman’s office should be 
notified if an address change is made. 
PERMISSION FOR AUTOPSY: In case of death, the family of the patient will be 
asked for permission to perform an autopsy. 
4. RISKS, SIDE EFFECTS AND DISCOMFORTS TO PARTICIPANTS: 
Two small additional biopsies will be required in addition to the initial biopsy. Risks 
from biopsies include coughing up blood which is usually slight. Severe hemorrhage 
which requires emergency treatment is rare. Biopsy of neck masses may also be 
associated with a slight risk of bleeding or infection. This clinical research study 
may involve unforeseeable risks to the participant. 
Recombinant DNA Research, Volume 20 
[663] 
